Ultrasound, Skin Permeation

Product Code: NRJ

General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)

Definition: Indicated For The Temporary Disruption Of The Outer Layer Of Skin For The Application Of Drugs, Etc.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4410

• Radiation Type: Acoustic
• Radition Safety: None
• Annual Reports: No

Products Classified as NRJ

5781

Ultrasound, Skin Permeation

Low Energy Ultrasound Wound Cleaner.

Total Product Life Cycle (TPLC) Devices

5781

Ultrasound, Skin Permeation

Low Energy Ultrasound Wound Cleaner.

FDA Consensus Standards

• Ultrasound, Skin Permeation [32412]: 21 CFR §878.4410 🔎

Pre-market Notifications for NRJ

K040525

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000

SONTRA MEDICAL INC.

Global Unique Device Identification Database

• 00810170018862: Ultrasound, skin permeation
• 00810170018848: Ultrasound, skin permeation
• 00810170018831: Ultrasound, skin permeation